非肌肉浸润性膀胱癌的麻醉方法和2年复发率:一项随机临床试验。

IF 5.1 2区 医学 Q1 ANESTHESIOLOGY Regional Anesthesia and Pain Medicine Pub Date : 2024-12-31 DOI:10.1136/rapm-2024-105949
Jang Hee Han, Hyeong Dong Yuk, Seung-Hwan Jeong, Chang Wook Jeong, Cheol Kwak, Jin-Tae Kim, Ja Hyeon Ku
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引用次数: 0

摘要

背景:麻醉方式对非肌肉浸润性膀胱癌(NMIBC)术后复发的影响尚不明确。我们的目的是比较脊髓麻醉(SA)和全身麻醉(GA)在NMIBC患者中的肿瘤学结果。方法:本前瞻性随机对照试验于2018 - 2020年在首尔国立大学医院招募287例临床NMIBC患者。患者在随机分组后4周内接受经尿道膀胱肿瘤切除术。SA组和GA组分别以鞘内高压布比卡因(0.5%)、异丙酚(1-2 mg/kg)和芬太尼(50-100 μg/kg)的混合物作为诱导剂,地氟醚或七氟醚维持麻醉。主要和次要结局指标分别是切除后2年的疾病复发和疾病进展。使用时间-事件分析比较两组间的累积结局发生率。结果:15例患者由于SA失败或明显的闭孔反射等临床需要需要替代麻醉,导致272例患者的意向治疗(ITT)改变。时间-事件分析显示,在ITT人群(27.4% vs 39.8%)和改良ITT人群(26.8% vs 39.6%)中,SA组NMIBC的复发率明显低于GA组。GA组比SA组更频繁地发生疾病进展(15.2% vs 7.8%),尽管差异无统计学意义。结论:SA患者的2年复发率明显低于GA患者。因此,SA可能被认为是首选的麻醉方法。试验注册号:NCT03597087。
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Anesthetic approaches and 2-year recurrence rates in non-muscle invasive bladder cancer: a randomized clinical trial.

Background: The effect of anesthesia methods on non-muscle invasive bladder cancer (NMIBC) recurrence post-resection remains uncertain. We aimed to compare the oncological outcomes of spinal anesthesia (SA) and general anesthesia (GA) in patients with NMIBC.

Methods: This prospective randomized controlled trial recruited 287 patients with clinical NMIBC at Seoul National University Hospital from 2018 to 2020. The patients underwent transurethral resection of the bladder tumor within 4 weeks of randomization. Intrathecal hyperbaric bupivacaine (0.5%) and a mixture of propofol (1-2 mg/kg) and fentanyl (50-100 μg/kg) were used as induction agents in the SA and GA groups, respectively, with desflurane or sevoflurane used for maintaining anesthesia. The primary and secondary outcome measures were disease recurrence and disease progression, respectively, at 2 years after resection. Cumulative incidence of outcomes was compared between the two groups using time-to-event analyses.

Results: 15 patients required alternative anesthesia owing to clinical needs such as SA failure or significant obturator reflex, resulting in a modified intention-to-treat (ITT) population of 272 patients. Time-to-event analysis showed a significantly lower recurrence of NMIBC in the SA group than in the GA group, in both ITT (27.4% vs 39.8%) and modified ITT populations (26.8% vs 39.6%). Disease progression occurred more frequently in the GA than in the SA group (15.2% vs 7.8%), although the difference was not statistically significant.

Conclusions: A notable reduction in the 2-year recurrence rate was observed in patients who underwent SA than in those who underwent GA. Thus, SA may be considered the preferred anesthetic approach.

Trial registration number: NCT03597087.

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来源期刊
CiteScore
8.50
自引率
11.80%
发文量
175
审稿时长
6-12 weeks
期刊介绍: Regional Anesthesia & Pain Medicine, the official publication of the American Society of Regional Anesthesia and Pain Medicine (ASRA), is a monthly journal that publishes peer-reviewed scientific and clinical studies to advance the understanding and clinical application of regional techniques for surgical anesthesia and postoperative analgesia. Coverage includes intraoperative regional techniques, perioperative pain, chronic pain, obstetric anesthesia, pediatric anesthesia, outcome studies, and complications. Published for over thirty years, this respected journal also serves as the official publication of the European Society of Regional Anaesthesia and Pain Therapy (ESRA), the Asian and Oceanic Society of Regional Anesthesia (AOSRA), the Latin American Society of Regional Anesthesia (LASRA), the African Society for Regional Anesthesia (AFSRA), and the Academy of Regional Anaesthesia of India (AORA).
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